System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

FDA classification

FDA Class 2 ·System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

Orientia Spp. (Scrub Typhus) Serological Reagents

FDA classification

FDA Not Classified ·Orientia Spp. (Scrub Typhus) Serological Reagents

Septal Stapler/Absorbable Staples

FDA classification

FDA Class 2 ·Septal Stapler/Absorbable Staples

Barrier, Animal Source, Intraoral

FDA classification

FDA Class 2 ·Barrier, Animal Source, Intraoral

Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

FDA classification

FDA Class 2 ·Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

11-Dehydro Thromboxane B2 Kit, Urinary

FDA classification

FDA Class 2 ·11-Dehydro Thromboxane B2 Kit, Urinary

Bacteriophage And Controls, B. Anthracis Lysis

FDA classification

FDA Class 2 ·Bacteriophage And Controls, B. Anthracis Lysis

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA classification

FDA Class 2 ·System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

FDA classification

FDA Class 2 ·Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

Breast Milk Macronutrients Test System

FDA classification

FDA Class 2 ·Breast Milk Macronutrients Test System

Immunohistochemistry Assay, Antibody, Ki-67

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Ki-67

Anti-Phospholipase A2 Receptor

FDA classification

FDA Class 2 ·Anti-Phospholipase A2 Receptor

Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

FDA classification

Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

Antigen, Cartilage Oligomeric Matrix Protein (Comp)

FDA classification

FDA Class 2 ·Antigen, Cartilage Oligomeric Matrix Protein (Comp)

Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

FDA classification

FDA Not Classified ·Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

FDA classification

FDA Not Classified ·Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA classification

FDA Class 3 ·Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Biliary Stent, Drain, And Dilator Accessories

FDA classification

FDA Class 1 ·Biliary Stent, Drain, And Dilator Accessories

Brain Trauma Assessment Test

FDA classification

FDA Class 2 ·Brain Trauma Assessment Test